Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren (Drug)
Phase: Phase 3
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceutical, Study Director, Affiliation: Novartis
This is a study for people diagnosed with hypertension to compare the safety and
effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in
the study for 12 weeks.
Official title: A Twelve-Week, Randomized, Double-Blind, Parallel-Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in diastolic blood pressure after 12 weeks
Change from baseline in systolic blood pressure after 12 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
Blood pressure of < 140/90 mmHg after 12 weeks
Minimum age: 18 Years.
Maximum age: N/A.
1. Outpatients 18 years of age and older.
2. Patients with essential hypertension.
Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary
form of hypertension, Participation in any investigational drug study within one month of
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Investigative Centers, Germany
Novartis, Basel, Switzerland
Starting date: November 2005
Last updated: November 9, 2006